心力衰竭患者心房颤动脉冲场消融的安全性和有效性

Safety and Effectiveness of Pulsed Field Ablation for Atrial Fibrillation in Patients With Heart Failure.

作者信息

Turagam Mohit K, Neuzil Petr, Schmidt Boris, Reichlin Tobias, Neven Kars, Metzner Andreas, Hansen Jim, Blaauw Yuri, Maury Philippe, Arentz Thomas, Sommer Philipp, Anic Ante, Anselme Frederic, Boveda Serge, Deneke Tom, Willems Stephan, van der Voort Pepijn, Tilz Roland, Funasako Moritoshi, Scherr Daniel, Wakili Reza, Steven Daniel, Kautzner Josef, Vijgen Johan, Jais Pierre, Petru Jan, Chun Julian, Roten Laurent, Füting Anna, Lemoine Marc D, Ruwald Martin, Mulder Bart A, Rollin Anne, Lehrmann Heiko, Fink Thomas, Jurisic Zrinka, Chaumont Corentin, Adelino Raquel, Nentwich Karin, Gunawardene Melanie, Ouss Alexandre, Heeger Christian-Hendrik, Manninger Martin, Bohnen Jan-Eric, Sultan Arian, Peichl Petr, Koopman Pieter, Derval Nicolas, Kueffer Thomas, Reinsch Nico, Reddy Vivek Y

机构信息

Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Cardiology Department, Na Homolce Hospital, Homolka Hospital, Prague, Czech Republic.

出版信息

JACC Clin Electrophysiol. 2024 May 18. doi: 10.1016/j.jacep.2024.05.002.

DOI:10.1016/j.jacep.2024.05.002

PMID:38864809

Abstract

BACKGROUND

Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF).

OBJECTIVE

This study sought to assess the outcomes of pulsed field ablation (PFA) in HF.

METHODS

MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a multicenter, patient-level registry of consecutive patients undergoing PFA for paroxysmal AF or persistent AF (PerAF). In this substudy, patients were stratified as no history of HF (no-HF), HF with preserved EF (HFpEF) (left ventricular EF of ≥50%) or HF with reduced/mildly reduced EF (HFmr/rEF) (left ventricular EF of <50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30 seconds and major adverse events, respectively.

RESULTS

Of the 1,381 patients, 85% (n = 1,174) were no-HF, 6.2% (n = 87) were HFpEF, and 8.6% (n = 120) were HFmr/rEF. No-HF patients had less PerAF than patients with HF (P < 0.001), with no difference between HF subtypes (P = >0.99). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF patients than in those with HFpEF or HFmr/rEF (79.9%, 71.3%, and 67.5%, respectively; P < 0.001) but similar between patients with HFmr/rEF and HFpEF (P = 0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFpEF vs HFmr/rEF for those with paroxysmal AF (82.8%, 82.4%, and 71.7%, respectively; P = 0.09) and PerAF (73.3%, 64.2%, and 64.9%, respectively; P = 0.14). Major adverse event rates were similar between the no-HF, HFpEF, and HFmr/rEF groups (1.9%, 0%, and 2.5%, respectively).

CONCLUSIONS

PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.

摘要

背景

心房颤动（AF）与心力衰竭（HF）并存，会增加发病率和死亡率。研究表明，射血分数降低（EF）的HF患者进行AF消融后预后得到改善。

目的

本研究旨在评估脉冲场消融（PFA）治疗HF的疗效。

方法

MANIFEST-PF（脉冲场消融批准后临床应用的方法、疗效和安全性多国调查）是一项多中心、患者水平的注册研究，纳入连续接受PFA治疗阵发性AF或持续性AF（PerAF）的患者。在这项子研究中，患者被分为无HF病史（无HF）、射血分数保留的HF（HFpEF）（左心室EF≥50%）或射血分数降低/轻度降低的HF（HFmr/rEF）（左心室EF<50%）。主要有效性和安全性终点分别为无持续≥30秒的记录在案的房性心律失常和主要不良事件。

结果

在1381例患者中，85%（n = 1174）为无HF，6.2%（n = 87）为HFpEF，8.6%（n = 120）为HFmr/rEF。无HF患者的PerAF少于HF患者（P < 0.001），HF各亚型之间无差异（P > 0.99）。无HF患者1年无房性心律失常的比例显著高于HFpEF或HFmr/rEF患者（分别为79.9%、71.3%和67.5%；P < 0.001），但HFmr/rEF和HFpEF患者之间相似（P = 0.26）。然而，对于阵发性AF患者（分别为82.8%、82.4%和71.7%；P = 0.09）和PerAF患者（分别为73.3%、64.2%和64.9%；P = 0.14），无HF、HFpEF和HFmr/rEF患者在无房性心律失常方面无显著差异。无HF、HFpEF和HFmr/rEF组的主要不良事件发生率相似（分别为1.9%、0%和2.5%）。